Psychological and Lifestyle Factors on Health Outcomes

NCT04780867 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1188

Last updated 2023-10-05

No results posted yet for this study

Summary

Psychosocial and lifestyle factors in Army recruits likely contribute to increased susceptibility to infection and injury during basic Army training. The primary aim of this study is to assess the influence of psychosocial and lifestyle factors at the start of basic Army training on immune health (e.g. respiratory infection and antibody response to influenza vaccination) and injury during training, in an observational design.

A secondary aim is to establish whether changes in psychosocial and lifestyle factors during training impact immune health (e.g. response to hepatitis B vaccination). Using an interventional design, participants will be randomly allocated into two experimental groups: (i) Routine vaccination group: to receive first hepatitis B vaccination at initial medical assessment upon entry to basic training and second hepatitis B vaccination 1 month later; (ii) Delayed vaccination group: to receive first hepatitis B vaccination during week 5 of training and second hepatitis B vaccination 1 month later.

Conditions

  • Psychological
  • Stress
  • Immune Health
  • Vaccination
  • Respiratory Tract Infections
  • Injury

Interventions

BEHAVIORAL

Delayed vaccination

First and second hepatitis B vaccinations will be delayed by 1 month in the interventional group to establish whether changes in psychosocial and lifestyle factors during training impact immune health.

Sponsors & Collaborators

  • University of Nottingham

    collaborator OTHER
  • University of California, Los Angeles

    collaborator OTHER
  • Loughborough University

    collaborator OTHER
  • Ministry of Defence, United Kingdom

    collaborator OTHER_GOV
  • Liverpool John Moores University

    lead OTHER

Principal Investigators

  • Neil P Walsh, PHD · Liverpool John Moores University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
33 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-19
Primary Completion
2023-01-31
Completion
2023-01-31

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04780867 on ClinicalTrials.gov